Gerstel: Intelligent Automation for GC/MS and LC.MS

USP 467


Implementation of USP <467> “Residual Solvents” using a GERSTEL MPS

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Keywords: Static Headspace, Residual Solvents, USP <467>

ABSTRACT

USP Residual Solvents [1] is a general chapter in the US Pharmacopeia that describes a headspace gas chromatographic method for the determination of residual solvents in pharmaceutical products, active ingredients, and excipients. As originally written, it described parameters used with balanced-pressure or pressure loop based headspace instruments. Recent updates [2] have included parameters for syringe based systems.

This application note demonstrates implementation of USP Residual Solvents using the GERSTEL MPS 2 configured as automated headspace sampler. Children’s non-aspirin (acetaminophen) suspension liquid was purchased locally and spiked to a level of 2000 μg/g (5 times the acceptable concentration limit) with acetonitrile.